TrueBinding

TrueBinding is a clinical-stage biotherapeutic company founded in 2016 that develops monoclonal antibody therapeutics targeting neurodegenerative diseases including Alzheimer's, Parkinson's, and Autism Spectrum Disorder, alongside stroke, metabolic disorders, and oncology. The company operates on a proprietary platform technology that enables rapid identification and validation of drug targets, with over six novel targets currently in development. Beyond therapeutic development, TrueBinding provides contract development and manufacturing (CDMO) services for biopharmaceutical partners, offering comprehensive capabilities from research and development through clinical manufacturing and distribution.

TrueBinding's service offerings span the full spectrum of biopharmaceutical development: DNA sequence analysis, cell line development, bioreactor screening, formulation development, and cGMP monoclonal antibody manufacturing at scales from 50L to 500L. The company maintains vivarium services for preclinical studies, including animal modeling, PK/PD studies, and safety testing in rodents. Their histology and imaging core provides tissue processing, immunohistochemistry, immunofluorescence staining, and confocal microscopy analysis. Additionally, TrueBinding offers media and buffer manufacturing from 1L to 3000L scale, with dedicated quality control and stability programs.

In 2023, TrueBinding received FDA approval for an Expanded Access Program under an Intermediate-Size Patient Protocol, the only one of its kind approved that year, enabling eligible patients with serious or life-threatening conditions to access investigational therapies. This program was renewed in 2024 and 2025. The company's manufacturing infrastructure includes remote monitoring of critical systems, audit-ready documentation, IND submission support, and a track record of successful drug substance production and clinical trial supply.